CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01283152
NCT01283152N/ACompleted
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Randomized Controlled Trial Evaluating the Efficacy of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) in Patients With Hepatic Encephalopathy.

University of Texas Southwestern Medical Center·interventional·Posted Jan 25, 2011·Updated Dec 11, 2014

In Brief

A clinical study evaluating Polyethylene glycol 3350-electrolyte solution (GoLYTELY®) and Lactulose for Hepatic Encephalopathy and 3 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy, PSE
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.4 years ago

Interventions

Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)drug

If randomized to this arm, subjects will receive a 1 time dose of 1 gallon

Lactulosedrug

If randomized to this arm, subjects will receive 10-30 grams per standard of care